Home NDC 0071-0737 Lopid
Product NDC 0071-0737
11-digit product format 000710737
Labeler code 0071
Product ID 0071-0737_c2888455-2200-497a-8e5a-10515dcb4f66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemfibrozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Parke-Davis Div of Pfizer Inc
Application NDA018422
Marketing category NDA
Marketing start 2004-03-30
Substance GEMFIBROZIL
Active strength 600 mg/1
Pharmacologic classes Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018422-001 LOPID GEMFIBROZIL 200MG CAPSULE / ORAL Approved before 1982 N018422-002 LOPID GEMFIBROZIL 300MG CAPSULE / ORAL Approved before 1982 N018422-003 LOPID GEMFIBROZIL 600MG TABLET / ORAL AB RLD, RS 1986-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018422-003 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018422-002 LOPID 300MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018422-003 LOPID 600MG TABLET / ORAL AB RLD, RS 1986-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018422-001 LOPID 200MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lopid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMFIBROZIL 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q8X02027X3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205751 Internal RxNorm lookup 310459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0071-0737-20 Lopid 60 in 1 BOTTLE TABLET, FILM COATED 60 23 0071-0737-30 Lopid 500 in 1 BOTTLE TABLET, FILM COATED 500 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded gemfibrozil ACTIVE INGREDIENT Q8X02027X3 LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 gemfibrozil ACTIVE MOIETY Q8X02027X3 LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0071-0737 LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 22 Current NDC, Legacy NDC, 2 package rows 20240716_c48855b7-215e-453b-b3b1-a0f9dee7221f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lopid GEMFIBROZIL Parke-Davis Div of Pfizer Inc c48855b7-215e-453b-b3b1-a0f9dee7221f 2026-05-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 018422 application number: NDA018422 ndc (product): 0071-0737
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0071-0737-20 00071073720 60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20) 2004-03-30 0000-00-00 No No Current 0071-0737-30 00071073730 500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30) 2004-03-30 0000-00-00 No No Current